Your session is about to expire
← Back to Search
Psychedelic
Psilocybin for Depression
Phase 2
Waitlist Available
Research Sponsored by Maryland Oncology Hematology, PA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is exploring whether a 25mg dose of psilocybin is safe and effective in treating cancer patients with depression.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
5 Dimension Altered State of Consciousness (5D-ASC)
Caregiver Oncology Quality of Life Questionnaire (CarGOQol)
Changes in electrocardiographs.
+13 moreSide effects data
From 2021 Phase 2 trial • 95 Patients • NCT020612939%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Psilocybin 25mgExperimental Treatment1 Intervention
Psilocybin 25mg Single does with supportive conditions.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Maryland Oncology Hematology, PALead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your depression score is 18 or higher during the screening and baseline assessments.Your personal circumstances or behavior make it difficult to build a trusting relationship or safely use psilocybin.You are currently receiving or have recently received chemotherapy or radiation therapy that affects your overall physical ability.You have signed the informed consent form.You have used drugs like psilocybin (magic mushrooms) or other psychedelics, except for medical marijuana, within the last year. Additionally, you have used psychedelics during your current episode of depression.You are able to understand and agree to participate in the study, as determined by the investigator.You must be 18 years or older during the first screening of the trial.Your depression level is high, as measured by the HAM D 17 score, during screening and baseline visits.You will be excluded if you have a history of certain psychiatric conditions.You have had thoughts of suicide or have engaged in suicidal behaviors within the past year, or a doctor has determined that you are at high risk for suicide based on your interview with them.You are not taking antidepressant, antipsychotic medications or medical cannabis during the screening process.You have a condition that causes seizures.You have been diagnosed with cancer as classified by ICD-10 codes C00 to C97.You have been diagnosed with major depression and it has been documented by a doctor or mental health professional.Your diabetes is not well controlled or you need to take insulin to manage it.You have been diagnosed with certain mental health conditions like schizophrenia, bipolar disorder, or borderline personality disorder.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin 25mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Depression Patient Testimony for trial: Trial Name: NCT04593563 — Phase 2
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger